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PharmacovigilanceMetrics Management & Operations
Oversight
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Mir Imran Ali M.Pharm, M.B.A, CCDM, PMP
Associate Director
Pharmacovigilance Center
Quintiles India - Bangalore
Overview
• Introduction to Pharmacovigilance Operations
• Key Performance Indicators
• Balanced Scorecard
• Dashboard
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• Dashboard
• Anticipated Challenges
• Ingredients for a successful Metrics
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Activities in Pharmacovigilance Operations
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Why Do we need Metrics ?
• To measure the organizational performance
– “You can’t manage something that you can’t
measure”
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• To facilitate the management to track and analyze
the performance of the business unit
• To ensure managerial effectiveness by providing
access to summarized information on various
performance metrics
Ascertaining KPIs
• Outline the strategy map based on the Balanced
Scorecard Methodology
• Feature four perspectives:
– Finance, Customer, Process and Learning and
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– Finance, Customer, Process and Learning and
Growth
• Ascertain strategies under each perspective
• Determine a set of measures for each strategy
• Present a drill down of these measures to the
Functional Heads/relevant stakeholders
Balanced Score Card
• BSC is an approach in strategic management developed
in the early 1990's by Dr. Robert Kaplan and Dr. David
Norton
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• It measures if an organization is meeting its objectives in
terms of vision and strategy
• BSC provides a comprehensive view thereby enabling
the organization to work on their best long term interests
Overview of the Balanced ScorecardOverview of the Balanced Scorecard
Vision
Strategy
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Strategy
Critical Success Factors
Organizational
Learning
Internal
Business
Process
CustomerFinancial
KPIs
StrategicInitiatives
A BSC Strategy Approach
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Present it on a Dashboard!
• Once KPIs are in place, create a dashboard containing all the key performance indicators with a snapshot of the defined metrics
• Provide relevant access to key stakeholders which would give the individual a glimpse of the organizational performance across the four perspectives
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across the four perspectives
– Different level of information will be required for different stakeholders
– This will extend managerial vision provide easy and quick access to summarized information
• Presenting the information on a defined 6 month/12 month rolling period along with coloured (Green, Yellow and Red) indicators will clearly indicate the direction the organization is heading on its various Strategic Objectives
Anticipated Challenges
• Limited automated processes and therefore largely dependant on manual data.
• Extensive involvement required from all stakeholders to define:
– KPIs
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– KPIs
– Formulas to be used
– Frequency of reporting
– Identification of owners for each metric
• Metrics integrity by automating and validation of all key metrics
Anticipated Challenges contd…
• Working with multiple platforms is challenging
• Operational staff usually focus more on projects
delivery and do not consider providing information
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delivery and do not consider providing information
for metrics high on their priority list
• Involvement of different support functions such as
Finance, Training, QA and HR adds to the
complexity
Ingredients for a successful Metrics
• Ensure buy-in from Senior Management is involved
• KPIs should be linked to business strategies
• Make it everyone’s job. Align it to performance goals and
incentives
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• Use it as a tool for:
– Continuous communication on
the Organizational Performance
– Empower the workforce
– Continuous improvement
– Sharing of learnings
Metrics Approach - Dashboard
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Metric Name
Contract Definition
SLA measure
Criteria
Reporting elements
Formulae
Frequency of metric collection
Success Story……
• In the Quintiles India Data Management group the metrics were driven by a Six Sigma approach where methodologies like BSC and Strategy Map were adopted.
• As a result they were able to:
– Achieve high visibility and acceptance on the importance of metrics
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– Get buy in from key stake holders
– Make it everyone’s job
– Ensure that the right metrics were monitored/had a plan to be monitored
– See that all metrics had a clear and agreed definition, formula, methodology of data collecting, frequency of reporting etc. and everything was clearly documented.
– Put in place a process to review the metrics on a periodic basis
• Learning from this team was adopted by the Pharmacovigilance Center
Acknowledgements
• Mr. Suresh Ramu Vice President and Regional Head, Asia, CDM
• Mr. Jacques Watson Senior Director and Head of Programming
• Ms. Susan Watson Senior Director, Pharmacovigilance Center
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• Ms. Susan Watson
• Ms. Nagalakshmi Shetty Manager, Clinical Data Management
• Mr. Rajesh Reddy Operations Scientist
Together we can “Improve Safety Profile, Promote Rational Use”
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